
The General Principles of Software Validation; Final Guidance (CSV), introduced in 2002 by FDA, is aimed at the validation of the software for medical device quality system and includes all aspects of the software development lifecycle, right from planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering. While recommending the integration of the software life cycle management with risk management, it puts the onus of the quality of the software on the device manufacturer even when it is not developed by them.